BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER 36/+0MM

    MDR report key: 12681474 · Received October 22, 2021

    Report

    Report Number
    3005180920-2021-00818
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES INVOLVED IN THE FIRST REVISION ((B)(6) 2021): BATCH REVIEW PERFORMED ON 28 SEPTEMBER 2021: LOT 2101810: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2021. EXPIRATION DATE: 2026-MAR-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 28 SEPTEMBER 2021: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2003852: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-APR-2021. EXPIRATION DATE: 2026-MAR-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. DEVICES INVOLVED IN THE SECOND REVISION SURGERY ((B)(6) 2021): BATCH REVIEW PERFORMED ON 28 SEPTEMBER 2021: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT 2101810: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2021. EXPIRATION DATE: 2026-MAR-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW PERFORMED ON 15 OCTOBER 2021: REVERSE SHOULDER SYSTEM 04.01.0112 HUMERAL REVERSE METAPHYSIS +0MM/+20°L LOT. (K170452) LOT 163789: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2016. EXPIRATION DATE: 2021-NOV-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. BATCH REVIEW PERFORMED ON 19 OCTOBER 2021: REVERSE SHOULDER SYSTEM 04.01.0186 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 13 (K180089) LOT 2003729: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUNE-2020. EXPIRATION DATE: 2025-JUNE-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ON (B)(6) 2021, ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING SHOULDER INSTABILITY AND THE CAUSE OF THE SHOULDER INSTABILITY IS UNKNOWN. THE SURGEON REVISED METAPHYSIS, LINER, AND DIAPHYSIS WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581138 REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER 36/+0MM HUMERAL REVERSE LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 2101810 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other